Actively Recruiting
To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer
Led by xiaohua li · Updated on 2025-02-05
118
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, exploratory clinical study. The primary endpoint of the study is to assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab. The aim is to evaluate the efficacy and safety of sintilimab in combination with bevacizumab in the perioperative neoadjuvant chemotherapy for rectal cancer. The study includes two cohorts: Cohort A involves a retrospective collection of rectal cancer patients who previously received the XELOX regimen in the perioperative setting. Cohort B includes rectal cancer patients undergoing perioperative treatment with sintilimab and bevacizumab combined with XELOX as a neoadjuvant regimen. Each of the trial group and historical control group requires 59 cases. The administration method for the trial group (Cohort B) is as follows: Sintilimab: 200 mg, intravenous, Day 1, every 3 weeks. Bevacizumab: 7.5 mg/kg, intravenous, Day 1, every 3 weeks. Chemotherapy regimen: XELOX regimen.
CONDITIONS
Official Title
To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rectal cancer patients who previously received perioperative XELOX regimen treatment (Cohort A)
- Signed written informed consent before any trial procedures (Cohort B)
- Non-bedridden patients, any gender, aged 18-75 years (Cohort B)
- Pathologically confirmed rectal adenocarcinoma, excluding anal squamous cell carcinoma (Cohort B)
- No prior antitumor treatment for rectal cancer; for Lynch syndrome patients, no related antitumor treatment (Cohort B)
- Tumor classified by MRI as T1-3bN1-2 or T3aN0 or T3bN0; no levator ani muscle involvement; negative mesorectal fascia and extramural vascular invasion; no cancerous nodules (Cohort B)
- ECOG performance status 0-1 (Cohort B)
- Expected survival longer than 3 months (Cohort B)
- Adequate organ function meeting specific laboratory criteria including neutrophil count, platelet count, hemoglobin, bilirubin, liver enzymes, creatinine, coagulation, thyroid function, and cardiac enzymes (Cohort B)
- For women of childbearing potential, a negative pregnancy test within 3 days before first dose (Cohort B)
- Use of effective contraception for all subjects at risk of conception during treatment and for 120 days after last investigational drug dose (Cohort B)
You will not qualify if you...
- Diagnosis of other malignant diseases within 5 years prior to first administration, except certain cured skin cancers
- Participation in other interventional clinical studies or use of investigational drugs/devices within 4 weeks prior to first administration
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or drugs targeting other T cell receptors
- Use of traditional Chinese medicine or immunomodulatory drugs with antitumor effects within 2 weeks prior to first administration
- Active autoimmune diseases needing systemic treatment within 2 years prior to first administration
- Systemic glucocorticoid treatment within 7 days prior to first administration, except low-dose physiological glucocorticoids
- Clinically uncontrollable abdominal effusion
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal)
- Allergy to sintilimab, bevacizumab, or related components
- Multiple factors affecting oral medication
- Incomplete recovery from prior treatment toxicities
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccine within 30 days prior to first administration, except inactivated influenza vaccine
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic diseases including serious heart conditions, unstable angina, recent arterial thrombosis, poorly controlled blood pressure, recent pneumonia or active lung diseases, active infections, liver diseases, poorly controlled diabetes, mental disorders, or other conditions interfering with study participation or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
W
wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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